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To demonstrate that patients treated with cangrelor can be directly switched to oral ticagrelor and that patients treated with ticagrelor can be switched to cangrelor without a significant decrease in the extent of inhibition of platelet aggregation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cangrelor IV + Ticagrelor 180mg at 0.5 hr | Experimental | On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h after the initiation of cangrelor infusion. |
|
| Cangrelor IV + Ticagrelor 90mg (7 doses) | Experimental | On Day 1: Following completion of cangrelor and ticagrelor dosing, patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 7 doses (12, 24, 36, 48, 60, 72, and 84 h). On Day 5: 12 h post last ticagrelor dose (90 mg), patients received another open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. |
|
| Cangrelor IV + Ticagrelor 180mg at 1.5 hr | Experimental | On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 1.5 h after the initiation of cangrelor infusion. |
|
| Cangrelor IV + Ticagrelor 90mg (6 doses) | Experimental | On Day 1: Following completion of cangrelor and ticagrelor dosing, patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 6 doses (12, 24, 36, 48, 60, and 72 h). On Day 5: 24 h post last ticagrelor dose (90 mg), patients received another open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cangrelor | Drug | Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Extent of Preservation of Inhibitory Effect Compared With Effect Observed With Cangrelor Alone (at Timepoint 1, Either at 0.5 Hours or 1.25 Hours) or Ticagrelor Alone (Measured 5.25 Hours After Initiation of Cangrelor on Day 1) | A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor. Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity (PR) was measured in response to 20 µmol adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response). | Day 1 measures taken at 2 timepoints after cangrelor infusion start: 0.5 or 1.5 hrs (Timepoint 1) and 5.25 hrs (TImepoint 2) |
| Extent of Preservation of Inhibitory Effect Compared With Effect Observed During Cangrelor Treatment After Ticagrelor | A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor. Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry (LTA). Residual platelet reactivity (PR) was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response). | Day 5 at 1.0 and 2.0 hours after the initiation of cangrelor infusion |
| Extent of Aggregation Response During Ticagrelor Treatment | Blood samples were taken for platelet function studies to conduct pharmacodynamic assessments including LTA. A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor. Residual platelet reactivity (PR) (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response). |
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Inclusion Criteria:
greater than / equal to 18 and less than 75 years of age
Previous myocardial infarction defined by admission to the hospital with elevation of markers of injury or the presence of pathologic q waves on at least 2 contiguous electrocardiogram (ECG) leads.
OR
Previous revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery.
AND
Treatment with aspirin (ASA) 81 mg daily.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J. Schneider, MD | University of Vermont Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fletcher Allen Health Care | Burlington | Vermont | 05401 | United States |
Patients with coronary artery disease who were taking aspirin, but not P2Y12 inhibition were enrolled.
The purpose of this study was to study the pharmacodynamic characteristics of transition from IV cangrelor to oral ticagrelor, and ticagrelor to cangrelor in patients with coronary artery disease. This was a single-center study, conducted in Jan-Feb 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Day 1 - Cangrelor + Ticagrelor (180mg) at 0.5h | Cangrelor IV (2h) + oral ticagrelor (180mg) administered at 0.5h after the initiation of the cangrelor infusion. |
| FG001 | Day 5 - Ticagrelor (90 mg) Dosing (6 Doses) | Ticagrelor (90mg) discontinued 24h prior to the initiation of a 2h cangrelor infusion. |
| FG002 | Day 1 - Cangrelor + Ticagrelor (180mg) at 1.5h | Cangrelor IV (2h) + oral ticagrelor (180mg) administered at 1.5h after the initiation of the cangrelor infusion. |
| FG003 | Day 5 - Ticagrelor (90mg) Dosing (7 Doses) | Ticagrelor (90mg) discontinued 12h prior to the initiation of a 2h cangrelor infusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1 |
| |||||||||||||
| Day 5 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ITT Population - Ticagrelor 6 Doses | On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h or 1.5 h after the initiation of cangrelor infusion. Patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 6 doses. On Day 5: Cangrelor was administered after ticagrelor (90 mg)was discontinued 24 hours prior. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Extent of Preservation of Inhibitory Effect Compared With Effect Observed With Cangrelor Alone (at Timepoint 1, Either at 0.5 Hours or 1.25 Hours) or Ticagrelor Alone (Measured 5.25 Hours After Initiation of Cangrelor on Day 1) | A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor. Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity (PR) was measured in response to 20 µmol adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response). | Posted | Mean | Standard Deviation | percentage of platelet reactivity (PR) | Day 1 measures taken at 2 timepoints after cangrelor infusion start: 0.5 or 1.5 hrs (Timepoint 1) and 5.25 hrs (TImepoint 2) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cangrelor + Ticagrelor 90mg (6 Doses) | Ticagrelor was discontinued 24 h prior to cangrelor infusion |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jayne Prats, PhD - VP, Global Knowledge Management | The Medicines Company | 888.779.MDCO | 1510 | jayne.prats@themedco.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C117446 | cangrelor |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
| Ticagrelor | Drug | Ticagrelor 180mg dose: administered 0.5 h or 1.5h after the initiation of cangrelor infusion Ticagrelor 90mg: 6 or 7 doses (depending on study arm) taken every 12 hours post cangrelor infusion. |
|
|
| Day 1 at 2.25, 2.5, 2.75, 3 and 4 hrs following initiation of cangrelor infusion |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | ITT Population - Ticagrelor 7 Doses | On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h or 1.5 h after the initiation of cangrelor infusion. Patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 7 doses. On Day 5: Cangrelor was administered after ticagrelor (90 mg)was discontinued 12 hours prior. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| All Patients |
| OG001 | Cangrelor + Ticagrelor 180mg at 1.25 h of Cangrelor Infusion | Cangrelor was administered as IV infusion for 2 hours. |
| OG002 | Cangrelor + Ticagrelor 180mg at 0.5 h of Cangrelor Infusion | Cangrelor was administered as IV infusion for 2 hours. |
|
|
| Primary | Extent of Preservation of Inhibitory Effect Compared With Effect Observed During Cangrelor Treatment After Ticagrelor | A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor. Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry (LTA). Residual platelet reactivity (PR) was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response). | Posted | Mean | Standard Deviation | percentage of platelet reactivity (PR) | Day 5 at 1.0 and 2.0 hours after the initiation of cangrelor infusion |
|
|
|
| Primary | Extent of Aggregation Response During Ticagrelor Treatment | Blood samples were taken for platelet function studies to conduct pharmacodynamic assessments including LTA. A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor. Residual platelet reactivity (PR) (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response). | Posted | Mean | Standard Deviation | percentage of platelet reactivity (PR) | Day 1 at 2.25, 2.5, 2.75, 3 and 4 hrs following initiation of cangrelor infusion |
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Cangrelor + Ticagrelor 90mg (7 Doses) | Ticagrelor discontinued 12 h prior to cangrelor infusion | 0 | 6 | 1 | 6 |
| Edema peripheral | General disorders |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
|
|
| 2.5 hours - PR |
|
| 2.75 hours - PR |
|
| 3 hours - PR |
|
| 4 hours - PR |
|